510(k) K102922 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
HARDYCHROM MRSA
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, May 4, 2011 |
| Received | Oct 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102922
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2020 | Hardy Diagnostics HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) Terminated |
JSO | None listed |
| Aug 26, 2015 | Hardy Diagnostics HardyCHROM MRSA
Cat no: G307 Lot no: H15155
Expires: 2015-08-13
Container Type: 15x100mm monoplate
Packaged: 10 plates/sleeve
Storage: 2-8C on receipt. Light Sensitive.
In vitro diagnostic
www.Har Terminated |
JSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.